Requirements: English
Company: Avara Pharmaceutical Services
Region: Milan , Lombardy
Purpose of the Role
We are seeking after a proactive and detail-oriented MS&T Specialist to support the seamless transfer of new manufacturing processes from other sites to our facility. This role will guide activities from pre-validation through process validation, including documentation for regulatory submissions. You will act as a key point of contact with clients throughout the transfer process and will also be responsible for cleaning validation of process equipment.
Key Responsibilities
- Lead all pre-validation activities for transferred products, including process review, water trials, machinability studies, placebo studies, and engineering runs.
- Coordinate activities on the production floor and interface with analytical labs to support validation work.
- Draft protocols and reports related to pre-validation, process validation, and cleaning validation activities.
- Contribute to the preparation and review of the Master Batch Record.
- Work with sterilizing filter suppliers for filter validation and review related documentation for regulatory submission.
- Serve as the main client interface during the process transfer and validation phases.
- Conduct cleaning validation for equipment in direct and indirect contact with products.
- Perform calculations for cleaning limits and support analytical labs in cleaning method validation.
- Collect field samples for cleaning validation testing.
- Act as Subject Matter Expert (SME) during client and regulatory audits.
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Required Qualifications
- Bachelors or Masters degree in Biological Sciences, Chemistry, Pharmacy, CTF (Pharmaceutical Chemistry and Technology), or Chemical Engineering.
- Minimum of 2 years of experience in a similar role within the pharmaceutical industry.
Technical Skills
- Solid understanding of GMP regulations and FDA requirements.
- Experience with aseptic manufacturing processes.
- Strong expertise in cleaning validation practices and documentation.
Soft Skills
- Strong analytical and problem-solving skills.
- Excellent organizational and planning abilities.
- Effective communication and leadership skills.
- Fluent in English (written and spoken).
This announcement is addressed to both sexes, in accordance with Laws 903/77 and 125/91, and to people of all ages and nationalities, in accordance with Legislative Decrees 215/03 and 216/03.
By applying to this announcement you authorize the processing of your personal data in accordance with Article 13 Legislative Decree No. 196 of June 30, 2003 - Code on the Protection of Personal Data and Article 13 GDPR 679/16 - European Regulation on the Protection of Personal Data.